Women’s health products are facing increased regulatory scrutiny and epidemiology is the driving force behind pre-market and post-market surveillance. This evolution is driven by the premise that people of different biological sexes have unique responses to disease, medications, therapies and even medical devices. It is a concept that is increasingly understood, but only recently changing the way regulators and companies identify sex-related safety signals in pre-market and post-market drugs and medical devices. A safety signal — which is information suggesting a potential association between a drug and adverse events — can result from a wide range of sources, including spontaneous case reports, data from an active surveillance system or literature findings.
Consider the global women’s health market. This product category includes everything from contraceptives and apps that help track ovulation, to treatments for health concerns like postmenopausal osteoporosis, hormonal infertility and menopause. On the rise since 2016, the market is expected to see a compound annual growth rate of about 5% through 2027.
Amid this growth, the Food and Drug Administration (FDA) publicized its decision to make product safety within the women’s health market a priority, which includes increasing its post-market surveillance activities. The FDA is relying on epidemiology to inform its enforcement in this space — a shift marked by a quick and decisive reversal of the FDA’s position on textured breast implants.
The FDA made an initial determination in May 2019 that a recall of textured breast implants was not required due to a lack of sufficient evidence. But in just two months, the agency obtained enough epidemiological evidence to warrant a recall, finding that the product put women at risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
As the legal team at King & Spalding warned in a recent New York Law Journal commentary, “case reports, case series, and adverse event reports are merely uncontrolled observations that are typically incapable of establishing causation. Thus, in almost all cases, analytical epidemiological evidence is necessary to reliably inform whether an exposure is causally associated with disease in human beings.” Companies must understand and utilize the tools available to help them understand safety signals. But the challenges will not be unique to the women’s health category.
As personalized medicine sees continued growth and products are increasingly customized for unique populations, the speed and accuracy of post-market product safety evaluations will determine a pharmaceutical or medical device company’s reputation and position in the marketplace. Regulators will be conducting their inspections and evaluations with every adverse event report. As will independent labs and the plaintiffs’ bar, and ultimately judges and juries.
Now is the time for companies to embrace and leverage all the insight epidemiology can offer. That includes re-evaluating your product recall plans and compliance programs to ensure that you are prepared if and when epidemiological evidence links your product to a potential adverse event.